Polycarbonate Syringes

GUDID B1605006B1

6cc Polycarbonate syringe, blue plunger

PROCEDURE PRODUCTS, INC.

General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: B1605006B1
• NIH Device Record Key: 7a76c2a1-8584-4fac-a836-a79152e9f679
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polycarbonate Syringes
• Version Model Number: 5006-B
• Company DUNS: 151507563
• Company Name: PROCEDURE PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1605006B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103736

FDA Product Code

• FMF: Syringe, Piston

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2017-04-03

On-Brand Devices [Polycarbonate Syringes]

• B1605006B1: 6cc Polycarbonate syringe, blue plunger
• B1605003Y1: 3cc Polycarbonate syringe, yellow plunger